1. Field of the Invention
This invention relates to medical articles, and, more particularly, relates to lubricious articles which inhibit or reduce bacterial growth in a living body during their use and to their preparation.
2. Background of the Invention
Polymeric materials such as polypropylene, polytetrafluoroethylene and polyurethane are frequently used to fabricate medical articles. These materials are for the most part inherently nonlubricious, yet are often used in invasive techniques such as catheterization in which a lubricious surface would contribute to patient comfort. Another problem encountered during use of medical articles which come into contact with a body tissue or fluid is infection, and a desirable feature of such articles is some means to control this complication. Accordingly, a variety of approaches to introduce these two features to plastic articles has been disclosed.
Spielvogel et al., in U.S. Pat. No. 4,720,521, teaches adherence of a lubricating composition to a surface. The composition includes a polysiloxane lubricant entrapped in a mixture of a plurality of reactive silicone components which, on curing, adhere to the surface and provide lubricity.
Many attempts to solve the problem of infection have been directed toward adherence of an antibacterial agent to the plastic article. Gould et al., in U.S. Pat. No. 3,695,921, discloses a catheter coated with a layer of hydrophilic polymer having an antibiotic absorbed therein.
EP published application No. 229,862 teaches thermoplastic polyurethane medical devices having an antimicrobial agent on its surface.
Fox et al., in U.S. Pat. No. 4,581,028, teaches infection resistant plastic medical articles, such as vascular grafts, having incorporated antimicrobial agents, such as silver sulfadiazine and pipericillin. The articles are prepared by dipping procedures.
Mustacich et al., in U.S. Pat. No. 4,479,795, discloses medical devices of permeable polymers including a releasably incorporated coating of a carboxylate antimicrobial agent which diffuses to the surface of the device to form an antimicrobial barrier.
In Japanese patent application No. SHO 60-36064 a polyurethane or silicone catheter is dipped into an aqueous solution of chlorhexidine to absorb the chlorhexidine into the polymer. The chlorhexidine is then converted to a water insoluble form by dipping into a solution of an acid. Japanese Pat. No. 59,228,856 discloses an elastomeric catheter having a water insoluble biguanide or salt thereof incorporated as a thin coating membrane in the surface of the catheter.
PCT published application No. WO 86/02561 teaches a medical device of a hydropho-bic thermoplastic polymer having up to 1% chlorhexidine base coated thereon or incorporated therein.
UK patent application No. 2,084,466A discloses a polypropylene article rendered biocidal with chlorhexidine base, and suggests that the article may be prepared from other plastics.
Solomon et al., in U.S. Pat. No. 4,713,402, discloses a method for attachment of a quaternary salt to the surface of a polymeric article and affixation of an antibiotic or antithrombogenic agent to the salt.
Although all of the above disclosures have addressed the separate problems of infection control and lubricity during use of medical articles, completely satisfactory solutions even to the individual problems have not yet been disclosed. The present invention is directed toward providing a common solution to both problems.